Automated cleaning system for dialyzers

ABSTRACT

A fully automated system for cleaning and disinfecting blood dialyzers is disclosed.

BACKGROUND OF THE INVENTION

The invention generally relates to a method and apparatus for cleaningartificial dialyzers which are employed as artificial kidneys indialysis treatments.

At present, the three general types of dialyzers which are known andavailable are the hollow fiber, parallel plate, and coil type dialyzers.

The hollow fiber dialyzer consists of multiple mutually parallel tubularmembranes in close proximity to one another. The core of the fiberscomprise the blood side of the dialyzer and the channels formed by theirexteriors from the dialysate side. Parallel plate dialyzers consist of aseries of parallel planar membranes. The membranes divide the dialyzerinto alternating blood and dialysate sides. The coil type dialyzerconsists of at least two membranes rolled into a spiral configuration.This configuration produces concentric circular pathways which formalternating blood and dialysate compartments.

After a dialysis treatment has been completed various membranes of thedialyzer are filled with a mixture of saline and blood. Historically,dialyzers in general were not thought to be reusable after the dialysistreatment. However, there have been attempts to design manual and/orsemi automatic systems which would wash and disinfect/sterilize thedialyzer in preparation for a subsequent dialysis treatment.

One such attempt is disclosed in U.S. Pat. No. 3,753,493 issued toMellor. This patent discloses a dialyzer apparatus which has a cleanwater inlet and an inlet for introducing cleaning and/or sterilizingliquids. Such liquids are then delivered into the water stream andcirculated in parallel through the dialysate and blood sides of thedialyzer in one direction. A timer is used to control the sequentialdelivery of the water flow and cleaning liquid through the dialyzer.This controller is simply a clock which sequences the steps of thecleaning process.

U.S. Pat. No. 3,871,913 issued to Shaldon discloses another system forcleaning a dialyzer. In Shaldon, a dialysis fluid, fresh water andsterilizing fluid are respectively introduced into the dialyzer forrespectively washing, rinsing and sterilizing it.

Both the Mellor and Shaldon systems fail to provide the necessaryidentification, monitoring, control and versatility necessary to producea truly safe, efficient and practical dialyzer cleaning system. Forexample, neither system provides tests during the cleaning process todetermine whether the dialyzer meets certain reusability criteria.

The systems lack the capacity to automatically machine sequence arepetition of cleaning steps or to automatically augment the cleaningsteps depending upon whether the dialyzer passes or fails thesereusability criteria. The systems do not provide for differing cleaningprocesses for the different types of dialyzers, nor do they provide forthe simultaneous application of differing cleaning steps to the bloodand dialysate sides of a particular dialyzer. In addition, the systemsalso lack the capacity to automatically inhibit the cleaning sequencesif the dialyzers are in a non-reusable condition. Finally, although itis known that a dialyzer should be reused only with the same patient,the systems lack safety checks necessary to insure that the properpatient will receive the proper dialyzer, and that, if any failures inthe system occur, they will be fully traceable and will not be used toinhibit any further cleaning.

As a consequence of the ineffectiveness of prior systems, dialyzers areroutinely discarded after each dialysis treatment, thus, making the costof such treatments even more expensive.

There is, therefore, a distinct need for a fully automated dialyzercleaning process and apparatus which will provide safe, efficient,versatile and controlled cleaning of dialyzers.

SUMMARY OF THE INVENTION

The disclosed invention obviates the above deficiencies in previousdevices by providing a fully automated cleaning system usable with allof the three currently available dialyzer types: parallel plate, coiland hollow fiber.

The inventive process comprises two phases: an identification phase anda cleaning phase. In the identification phase, an identification of thepatient who has a particular dialyzer is made to insure that saidparticular dialyzer will be reused only with that same patient. Thispatient number is also stored and used to determine the number of timesthe particular dialyzer has been cleaned; i.e., reused. Additionally,the dialyzer type is identified to allow the cleaning sequence to betailored for the particular type of dialyzer. The system can providemultiple, simultaneously operating cleaning stations and, therefore, aspart of the identification phase, the particular station number used toclean each dialyzer is identified and stored to provide traceability.

The cleaning phase comprises a predetermined sequence of steps,typically broken into sub-sequences, which are selectable for cleaningthe particular types of dialyzers. An important feature of the inventionis that the cleaning sequences used to clean parallel plate and coiltype dialyzers differ from that used to clean hollow fiber dialyzers.This is due to the recognition that the planar membrane interfaces ofthe parallel plate and coil dialyzers permit and require differingcleaning steps from the tubular configuration of the hollow fiber type.

The cleaning sequence comprises plural rinsing anddisinfecting/sterilizing steps, interspersed with blood presence,pressure leakage tests and volume or ultrafiltration rate analyses.Failure of the dialyzer to meet any of the predetermined criterianecessary to pass these analyses results in the repetition of cleaningsub-sequences, or the rejection of the dialyzer as non-reusable and aninhibition of the cleaning sequence. The system is also capable ofsimultaneously applying different cleaning procedures to the blood anddialysate sides of the dialyzer being cleaned.

The apparatus employed for practicing the invention is a fullyautomated, modular machine to which additional stations may be added toprovide simultaneous cleaning of multiple dialyzers. The flow of air,cleaning, disinfecting and/or sterilizing fluids is regulated by aseries of valves and pumps which are, in turn, controlled by theelectronics of the system. Each station is capable of operatingindependently, the electronics providing monitoring, recording andlogging functions for all stations.

The system, therefore, has the capability of providing differentcleaning processes for differing types of dialyzers, for performingvarious reusability checks to determine whether the cleaning process isproceeding properly, and has the ability to inhibit the furthersequencing or to add additional cleaning sequences if the various testsare not passed. If any malfunction in the system occurs during theoperation, the operator is made aware of the site of the problem bymeans of various malfunction indicators. The system, therefore, insuresthat a dialyzer is properly cleaned, is ready for reuse, and is returnedfor use only with the proper patient.

These and other advantages will become more apparent in the discussionbelow, which makes reference to the following set of drawings, wherein:

FIG. 1 is a perspective view of the dialysis cleaning machine, includingthe front control panel;

FIG. 1a is an enlarged, elevation view of the front control panel shownin FIG. 1;

FIG. 2 is a schematic diagram of the mechanical elements of the machineshown in FIG. 1;

FIG. 2a is a more detailed schematic diagram of the blood analyzer shownin FIG. 2; and

FIG. 3 is a schematic diagram of the electronics of the machine shown inFIG. 1.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring to FIG. 1, the dialyzer cleaning apparatus is shown generallyas 10. The apparatus 10 has two cleaning stations 12 and 14, and mayinclude any number of additional cleaning stations. Thus, the apparatus10 is modular in concept, so that a selectable number of dialyzers maybe washed simultaneously.

Each station 12, 14 is capable of washing any type of dialyzer. As shownin FIG. 1, parallel plate dialyzers 16, 18 are shown connected tostations 12, 14 respectively for cleaning. A coil type dialyzer orhollow fiber type dialyzer (not shown) could equally well be attached toeither station 12, 14. Each of these dialyzer types includes a dialysateside and blood side, each provided with a connector for attachment to anarterial and a venus tube. An arterial blood side tube 24, and a venusblood side tube 26 extend from the fluid flow control devices within theapparatus 10 for connection to the dialyzers 16, 18. A photo-opticalinput is produced by a digital data reading wand 30 which reads digitaldata from a label 31 which identifies the dialyzer type, patient numberand dialyzer serial number or equivalent identification.

The cleaning apparatus 10 also includes a front panel 36 which containsa number of gauges, switches, lights and displays, as more clearly shownin FIG. 1a. A power-on switch 38 may be pressed by an operator toactivate the apparatus 10. Thereafter, the operator may activate astation preparation switch 40 to prepare the particular station 12, 14for the cleaning of a dialyzer 16, 18 prior to the dialyzer 16, 18connection. The panel 36 also includes a number of switches and lights37 for control and monitoring of the identification phase of theprocess. These include a station number switch 42 which is pressed toactuate a display 44, which provides the station number. It should beunderstood that there will be a different station number switch for eachparticular station. The switch 42 also records this station numberwithin the system electronics, as described below. A patient numberdisplay 46 is provided to notify the operator of the patient number readby the wand 30. Three lights 48, 50, 52 are provided to warn theoperator that (a) no station number has been identified, (b) no patientnumber has been identified, and (c) no dialyzer type has been identifiedrespectively.

The next group of lights 53 indicates that there is a malfunction in thesystem. Thus, lights 54-70 are individually labled on the panel 36 tonotify the operator of the nature of any malfunction. The specificpurpose of each light in the group 53 will be described below.

The next two lights 72, 74 indicate the status of the dialyzer beingcleaned. Accept light 72 indicates that the status of the dialyzer isacceptable and reject light 74 indicates that the dialyzer has beenrejected for a particular failure as will be described.

In the second column of the panel 36, a time to completion display 76indicates the total time needed to complete an entire cleaning cycle.

The next two series of lights and switches 75, 77 provide the operatorwith a visual indication of the cleaning plate in progress during twodistinct cleaning phases which are described below. Lights 80-98, 102,104, 108, 112 and 114 thus show the cycle in progress, while lights 100,106 and 110 alert the operator of analysis failures. A switch 78 is usedto begin the cleaning process.

Finally, a cleaning complete light 116 indicates that the entirecleaning phase is complete.

The remainder of the panel 36 consists of a reset switch 118 which ismanually actuated by the operator to reset the cleaning apparatus 10 tothe beginning of the cleaning phase, ready for another cleaningoperation. Finally, secure station switch 120 is manually actuated bythe operator when the system is to be shut down.

Referring now to FIG. 2, the hydraulic and pneumatic control elements ofthe apparatus 10 may be described. A dialyzer 18 is shown schematicallyin the center of the figure, and involves a dialysate side 122 and ablood side 124 separated by a membrane 123. This dialyzer may be anytype, i.e., parallel plate, coil or hollow fiber.

The arterial dialysate side tube 20 is connected to a drain line 126,leading to a drain or sewer system, and a pressure line 128 leading to apressure pump P₁₄ which has a malfunction sensor 130. The flow of fluidsthrough the drain line 126 is controlled by a valve V₆, while the rateof flow of fluid through the drain line 126 is measured by a flow meterF₂. The rate of flow of air through the pressure line 128 is regulatedby valve V₁₂. The air which flows through pressure line 128 may besupplied from a reservoir (not shown), and is filtered by means of afilter 132.

The venus dialysate side tube 22 is connected to a formalin supply line134, an R.O. water (i.e. reverse osmosis water) supply line 136, and adrain line 138. Formalin is pumped through the formalin line 134 from areservoir 142 by means of a formalin pump P₁₅. The flow of formalinbeing measured by a flow meter F₃. A sensor 140 monitors any malfunctionin the formalin pump P₁₅, while a formalin supply sensor 144 provides awarning when the quantity of formalin is low.

The arterial blood side tube 24 is connected to a drain line 146, anR.O. water line 1148 and an air pressure line 150. Flow of a fluidthrough the drain line 146 is controlled by valve V₇. The drain line 146also includes a blood analyzer unit 152 and a flow meter F₁. A pump P₁₇,supplies R.O. water to the line 148 from a reservoir 182, the flow beingcontrolled by a valve V₁₀. A valve V₁₁ connects the pressure pump P₁₄ tothe tube 24.

The venus blood side tube 26 is connected to a pressure transducer 158which is used for the pressure leak and ultrafiltration rate testsdescribed below. The tube 26 is connected to an R.O. water supply line160 and a hypochlorite line 161 through a valve V₂, a peroxide line 162controlled by a valve V₃ and monitored by a flow valve V₄, a formalinline 164 and a drain line 166. A hydrogen peroxide pump P₁₃, monitoredby a malfunction sensor 168, is used to pump hydrogen peroxide throughthe peroxide line 162 from a reservoir 170, which includes a levelindicator 172. A sodium hypochlorite pump P₁₆, monitored by amalfunction sensor 174, is used to pump a detergent such as sodiumhypochlorite through a one way check valve 163 in the hypochlorite line161 from a reservoir 176, monitored by a level sensor 178.

The flow of formalin from the pump P₁₅ through the formalin line 164 isregulated by a valve V₄, and is measured by a flow meter F₃. The rate offlow fluid through the drain line 166 is controlled by valve V₈.

R.O. water is pumped through each of the R.O. water lines 136, 148 and160 by means of an R.O. water pump P₁₇, including a malfunction sensor180, connected to a R.O. water reservoir 182 which has an R.O. watersupply indicator 184. If desired, the R.O. water contained in R.O. waterreservoir 182 may be heated to approximately 60° F.-70° F. by a heater183. As is well known to those in the art, an R.O. water producingmachine (not shown) supplies R.O. water to reservoir 182. It should alsobe understood that an acceptable alternative to the R.O. water is softwater.

Relating FIG. 2 to FIG. 1a, when the R.O. water supply is low, asindicated by R.O. water supply indicator 184, R.O. water low light 54 islit. When either the supply of peroxide or sodium hypochlorite is low,as indicated by peroxide supply indicator 172 and sodium hypochloritesupply indicator 178, respectively, detergent low light 56 is lit.Disinfectant low light 58 indicates that the supply of disinfectant islow as indicated by formalin supply indicator 144. When R.O. pumpmalfunction sensor 180 indicates that the R.O. pump P₁₇ ismalfunctioning, R.O. pump malfunction light 60 is lit. When eitherperoxide pump malfunction sensor 168 or sodium hypochlorite pumpmalfunction sensor 174 indicates that the perioxide pump P₁₃ or sodiumhypochlorite pump P₁₆ are malfunctioning, detergent pump malfunctionlight 62 is lit. Disinfectant pump malfunction light 64 indicates thatthe formalin pump malfunction sensor 140 senses that the formalin pumpP₁₅ is malfunctioning. When air pressure pump malfunction sensor 130indicates a malfunction in the pressure pump P₁₄, air pump malfunctionlight 66 is lit. If any malfunction develops in the R.O. water producingmachine, the R.O. supply light 68 is lit.

It should be understood that, although formalin is the preferredsterilizing medium, any of the well known disinfectants for sterilizing,such as glutaraldehyde are acceptable. It should also be understood thatother detergents other than sodium hypochlorite are acceptable. Thepreferred detergent is a sodium hypochlorite sold and manufactured underthe trademark Clorox Bleach by Purex Corporation. Similarly, althoughhydrogen peroxide is the preferred oxidizing medium, any oxidizingmedium which is non-pyrogenic, nonexplosive, nontoxic and is compatiblewith a dialyzer membrane is acceptable, such as, glutathione.

Referring now to FIG. 2a, the details of the blood analyzer 152 will bedescribed. The blood analyzer 152 includes a clear plastic tubularinsert 186 which forms a length of the arterial blood side drain line146. A chemical reagent 188 is contained in a reservoir 190, and flowsinto a cylinder 192 through a check valve 194. A piston 196 in thecylinder 192 is reciprocated by a solenoid P₁₈. When piston 196 israised in the cylinder 192, chemical reagent 188 is drawn into thecylinder 192. Then, as the piston 196 is forced downward by the solenoidP₁₈, the chemical reagent 188 within the cylinder 192 is forced into theplastic insert 186 through another check valve 198, which when forcedinto the plastic insert 186, mixes with the wash effluent and turnscolor with the presence of blood. The cylinder 192 permits an accuratelymeasured quantity of reagent to be admitted to the insert 186 duringeach cycle of the solenoid P₁₈.

A light source 200 is positioned to illuminate the plastic insert 186and its contents. A first photocell 202 is positioned to measure thelight passing through the insert 186 from the source 200. A secondphotocell 204 is positioned to directly measure the level of the light200. The first photocell 202 and second photocell 204 are connected asinputs to a differential amplifier 206. The differential amplifiermeasures a difference in electrical output from the first photocell 202and second photocell 204 to compare the amount of light which reachesthe two photosensors. This, in turn, is dependent upon the amount ofblood in the fluid within the insert 186 which will produce the colorchange in the chemical reagent 188. When the differential amplifiersenses a given voltage difference, a signal is produced on output line207. It will be understood that the use of the two photocells 202, 204and amplifier 206 cancels out the effects of changing brightness of thesource 200.

The entire cleaning procedures will now be described in reference toseveral tables, and FIGS. 1a, 2 and 2a. In the first step in theprocess, the operator manually actuates the power on switch 38. Next,the operator manually actuates the station preparation switch 40.

The next sequence of steps, steps 3-11, comprise the station preparationcycle sequence, which is set forth in Table I, and which occurs withouta dialyzer 18 connected to the apparatus.

Thus, during this cycle, the arterial dialysate side line 20 isconnected to the venus dialysate side line 22 and the arterial bloodside line 24 is connected to the venus blood side line 26 by means ofjumper tubes shown on FIG. 2. Table I describes the control sequences,functions and step time for steps 3 through 11. The first, far left-handcolumn of Table I indicates the step number. The second column indicatesthe time, expressed in seconds, for each particular step. The thirdcolumn indicates the control sequence which is performed on the bloodside of the dialyzer 124, while the fourth column reflects the resultingblood side function. The fifth column indicates the control sequence forthe dialysate side 122 of the dialyzer, and the final, sixth columnindicates the resulting dialysate side function.

As will be understood from the detailed description of FIG. 3 below, thesteps of Table I, as well as the remaining tables, now to be described,are automatically controlled by an electronic sequencing system, exceptwhere manual actuation is described. Thus, once initiated, the cleaningcycles proceed, in sequence, automatically.

Referring to Table I, Step No. 3, which requires seventeen seconds, isperformed by turning on the R.O. water pump P₁₇ and opening valves V₂and V₁. The normal position of the valves V₁ through V₁₂ is normallyclosed, except for V₆ and V₇, which are normally open. The normal stateof the pumps P₁₃ through P₁₇ is off. Opening the valve V₂ allows R.O.water to flow through the blood side 24 of the dialyzer 18, producing aforward rinse as a blood side function. Similarly, opening the valve V₁allows R.O. water to flow through R.O. water line 136 to the dialysateside 122 of dialyzer 18, producing a forward rinse on the dialysateside.

Step 4 requires thirty-four seconds. On the blood side 124, the controlsequence is to close valve V₇, open valve V₈ and open valve V₁₁. The airpressure pump P₁₄ is turned on. These control sequences produce an airpurge through the pressure line 150, which continues through the bloodside 124 of the dialyzer. On the dialysate side 122, the valve V₁ isopened and the pump P₁₇ is actuated to continue the forward rinse.

Step 5 requires thirty-four seconds. The blood side control sequencecloses the valve V₇, opens the valve V₈, closes the valve V₁₁ and opensthe valve V₁₀. In addition, the R.O. water pump P₁₇ is actuated. Thisproduces a reverse rinse of R.O. water through the blood side 124 of thedialyzer 18. With respect to the dialysate side 122, the valve V₁remains open and the pump P₁₇ remains on to produce a forward rinse.

Step 6 requires the thirty-four seconds to complete. The functions onboth the blood side 124 and dialysate side 122 are forward rinses andare obtained in the same manner as in Step 3.

Step 7 requires thirty-four seconds. The blood side function is an airpurge and the dialysate function is a forward rinse which are obtainedin the same manner as in Step 4.

Step 8 requires thirty-four seconds. The blood side function is areverse rinse and the dialysate side function is a forward rinse whichare obtained in the same manner as in Step 5.

Step 9 requires thirty-four seconds to complete. The functions on boththe blood side 124 and dialysate side 122 are forward rinses, and areobtained in the same manner as in Step 3.

Step 10 requires thirty-four seconds. The blood side 124 function is anair purge and the dialysate side 122 function is a forward rinse,obtained in the same manner as Step 4.

Step 11 requires thirty-four seconds to complete. It produces a reverserinse on the blood side 124 and a forward rinse on the dialysate side122, and is produced by the same sequencing as found in Step 5.

This completes the preparation cycle for the system.

The next step, Step 12, requires the operator to manually disconnect thejumpers and connect the dialyzers 18 to their stations.

At the next step, Step 13, the operator manually presses the stationnumber button 42, which will then indicate the station number on thedisplay 44. If the station number is not depressed, the light 48 willlight, and further sequencing is inhibited. The recording of the stationnumber allows the system electronics, described below, to determine atwhich station the particular dialyzer 18 was cleaned. This providessystem traceability, so that, if any problem occurs, for example, in adialysis treatment with a particular dialyzer which has been cleaned,the faulty station may be determined and repaired.

Step 14 requires the manual inputing of the patient number, which isdisplayed in the patient number display 46. The patient number iscomposed of the last four digits of a person's social security number,and is attached, in the form of a machine readable code, on label 31, tothe particular dialyzer. The patient number is read by providing aphoto-optical input from a device such as a reading wand 30, well knownin the art. If no patient number is entered, the "no patient's number"light 50 will light, and the system electronics will inhibit any furthersequencing. The patient's number also provides a means of determiningthe number of times a particular dialyzer has been cleaned. Thus, thepatient's number is stored, and the system electronics counts the numberof times each patient number is stored. The patient number is alsoextremely important in that, when the particular dialyzer aftercleaning, is to be used again in a dialysis treatment, a reading wand isused to sense the patient's number. If, for any reason, that dialyzerhas been rejected by the apparatus 10 during cleaning, the patientnumber is automatically dropped from the memory. Thus, a comparator, aswill be described later, functions to compare the incoming patientnumber with the stored patient numbers. If no corresponding patientnumber is found, the "no patient number" light 50 will light, indicatingto the operator that that particular dialyzer should not be used.

Step 15 involves entering the dialyzer type. This is done by means ofthe reading wand 30 or other suitable photo-optical input which reads analphabetical designation that is placed on the dialyzer itself inmachine readable form. Thus, for example, H.F. would indicate a hollowfiber dialyzer; P.P.D. would indicate a parallel plate dialyzer and C.O.would indicate a coil dialyzer. This dialyzer type is in the systemelectronics, and is used to determine the proper cleaning sequence, aswill hereinafter be described. If no dialyzer type is entered, "nodialyzer type" light 52 will illuminate, and will inhibit any furthersequencing.

Thus, in order for the cleaning process to begin, the electronics mustbe provided with a complete set of identifications, from Steps 13, 14and 15.

Once the identification process is complete, cleaning phase 1 isinitiated, and the time required to complete the cleaning process willbe automatically displayed on the "time to completion" display 76.

Step 16 comprises manually actuating the cleaning phase 1 with switch78. The first portion of cleaning phase 1 is a prerinse cycle which iscomposed of Steps 17 through 25. During the prerinse cycle, the prerinselight 80 is lit. These are outlined in Table II. One will note that theSteps 17 through 25 of the prerinse sequence are the same as Steps 3through 11 of the station preparation cycle.

Thus, the valving and pump sequencing will not be discussed again. Itwill be understood that the Steps 17 through 25 consist of three, threestep cycles. On the blood side 124, the cleaning cycle is to apply aforward rinse, an air purge and then a reverse rinse. All three cleaningsteps function to dislodge and flush away blood components from thedialyzer membranes. The air purge serves the additional function ofremoving moisture from the blood side 124. Traditionally, cleaningprocedures have employed fluid flushes in one direction only. However,this inventive process employs rinsing in both directions which has beenfound to increase the agitation of the dialyzer membranes, therebyproducing a cleaner dialyzer in a shorter period of time. The dialysateside function throughout Steps 17-25 is a forward rinse which not onlyserves to flush the dialysate side, but also provides a counterbalancingpressure against the pressure produced by the blood side functions. Thisfluid pressure helps to prevent a rupture of membranes which would tendto occur without such counterbalancing pressure.

Upon completion of the prerinse sequence, the system electronics willselect a cleaning sequence that is specific to the attached dialyzertype. Thus, there is a rinse cycle which is specific to a hollow fibertype of dialyzer, and another rinse cycle which is specific to parallelplate and coil type dialyzers.

Table III reflects the cleaning sequence specific to a hollow fiber typedialyzer which will now be described. Step 26 requires four minutes tocomplete. The blood side control sequence opens the valve V₈, whichopens the venus blood side drain line 166. The dialysate side controlsequence opens the valve V₁, closes the valve V₆, and turns on the R.O.water pump P₁₇. With the valve V₁ open and the pump P₁₇ on, a forwardrinse is provided on the dialysate side 122. However, the closing of thevalve V₆ provides a build-up of pressure within the dialysate side 122.Thus, with the venus blood side drain line 166 open, this fluid pressurebeing exerted against the membrane wall 123 of the dialyzer, causes asqueezing of the blood side 124.

This squeezing of the blood side 124 has been found to be a highlyeffective cleaning step by serving to dislodge and to expel bloodcomponents from the blood side of the dialyzer. The physicalconfiguration of the hollow fiber membrane permits the utilization ofsuch pressure. This step is not employed with parallel plate and coildialyzers since as presently manufactured, their flat membraneinterfaces would tend to rupture under this squeezing.

Step 27 requires two minutes to complete. The blood side controlsequence is to close the valve V₇, open the valve V₈ and to open thevalve V₁₀. In addition, the R.O. water pump P₁₇ is activated. Thisproduces a reverse rinse in the blood side 124. The dialysate side 122control sequence opens the valve V₉. This produces a drain opencondition in which the venus dialysate side drain line 138 is open.

Step 28 requires two minutes to complete. The blood side controlsequence opens the valve V₂ and turns on the R.O. water pump P₁₇, whichproduces a forward rinse on the blood side 124. On the dialysate side122, the valve V₉ remains open, so that the dialysate side function is adrain open position.

Step 29 requires four minutes to complete and is the same as Step 26, inwhich the dialysate side 122 function is a forward rinse which squeezesthe blood side 124, which has venus blood side drain line 166 open.

Step 30 requires two minutes to complete and is the same as Step 27,having a reverse rinse on the blood side 124, and a drain open conditionon the dialysate side 122.

Step 31 requires two minutes to complete and is the same as Step 28,having a forward rinse on the blood side 124 and a drain open conditionon the dialysate side 122.

This completes the specific sequencing for a hollow fiber type ofdialyzer. During this hollow fiber specific rinse, "hollow fiber rinse"light 82 is lit.

Table IV illustrates Steps 32-35, the rinse sequence specific toparallel plate and coil type dialyzers. Thus, if a parallel plate orcoil type dialyzer is being cleaned, the system, after completing Step25, will automatically sequence to Step 32.

Each of the four steps requires four minutes to complete. The sequenceconsists of two, two step sub-sequences. Each sub-sequence applies firsta forward and than a reverse rinse to the blood side 124. As has beendiscussed, the cycling of forward and reverse rinses has been found tobe quite effective in the removal of blood components from the dialyzermembranes. The dialysate side function throughout the sub-sequence is adrain open condition in which the drain lines 138 and 126 are open.

This completes the parallel plate and coil type dialyzer specific rinsesequence. During this sequence, the "parallel plate dialyzer rinse"light 84 is on.

With the completion of the specific rinse program, the sequencecontinues with the common, main cleaning steps of the cleaning process,referred to as cleaning phase 2 on the panel 36.

Table V contains the sequence cleaning phase 2, which is common to alltypes of dialyzers. It begins with Step 36, which requires one minute tocomplete. This step is generally the first blood level analysis.

Step 36 follows either Step 31 in the case of a hollow fiber dialyzer orStep 35 in the case of a parallel plate or coil dialyzer. In Step 31 theblood side 124 function is a forward rinse and in Step 35 it is areverse rinse. Thus, in either case, there is rinse water in thearterial and venus blood side tubes 24 and 26 respectively. In order tobegin the analysis, the valves are placed in their normal condition onboth the blood and dialysate sides. On the blood side 124, this wouldrequire closing either the valve V₂ in the case of a hollow fiberdialyzer or opening the valve V₇ and closing the valves V₈ and V₁₀ inthe case of a parallel plate or coil dialyzer. In this condition, thereis effluent remaining in the arterial blood side drain line 146. As hasbeen described, the blood analysis is performed by the blood analyzer152. A metered amount of the chemical reagent 188 is infused into theplastic insert 186 and reacts with the effluent. The chemical reagent188 is preferably a hemoglobin reagent. Such blood test compositions aredisclosed in U.S. Pat. Nos. 3,012,976 and 3,092,463 which are hereinincorporated by reference. After metering in the chemical reagent 188,the system delays ten seconds. The differential amplifier 206 thencompares the voltage outputs from the first and second photocells 202and 204. The differential amplifier 206 is adjusted to produce an outputsignal on line 207 if the content of blood components in the effluent isgreater than about 2-4 milligram of hemoglobin per 1-200 milligrams ofeffluent. During this first blood level analysis, the "first blood levelanalysis" light 86 is lit. If the dialyzer passes this blood level test,the system cycles forward to Step 48, which is the first step in thepressure leak test, which will hereinafter be described. If the dialyzerdoes not pass the first blood level analysis, the process is incrementedone step to Step 37, which is an air purge as will more specifically nowbe described.

Steps 37 and 38 represent a two step sub-sequence in which first thedialysate side 122 and then the blood side 124 are submitted to an airpurge. The function of the corresponding dialyzer side in each step isopen to drain. Thus, in step 37, the blood side 124 is squeezed from thepressure of the dialysate side 122 air purge, thereby expelling anddislodging blood components. In Step 38, the dialysate side 124 issqueezed while the blood side 122 undergoes an air purge.

Step 37 requires thirty seconds to complete. The valve V₆ is closedthereby closing the arterial dialysate side drain line 126. The valve V₉is closed thereby closing the venus side drain line 138. The valve V₁₂is opened thereby opening arterial dialysate side pressure line 138.Activation of the pressure pump P₁₄ produces a flow of air through thedialysate side 122, thus producing the air purge.

Step 38 requires thirty seconds to complete. The air pressure pump P₁₄remains on. The valve V₇ is closed thereby closing the arterial bloodside drain line 146. The valve V₈ is closed thereby closing the venusblood side drain line 166. Opening of the valve V₁₁ and the activationof air pressure pump P₁₄ produces a flow of air through the blood side124 and the described air purge. While Steps 37 and Step 38 are inprogress, the "purge" light 88 is lit.

Step 39 begins the first detergent cycle and requires three minutes tocomplete. The blood side 124 control sequence opens the valve V₃ andturns the peroxide pump P₁₃ on. The opening of the valve V₃ opens theblood side detergent line 162 so that peroxide can flow into the bloodside 124 from pump P₁₃ and the reservoir 170. The valve V₈ remainsclosed from Step 38, and thus the blood side 24 of the dialyzer 18 willbe filled with peroxide. The dialysate side 122 control sequence placesall valves in a normal condition, so that the dialysate side 122 is opento drain.

The next step, Step 40, requires four minutes to complete. There are nochanges in the blood dialysate side control sequence. The blood sidecontrol sequence closes the valve V₃ and turns the pressure pump P₁₃off. This produces a delay function, with the blood side 124 remainingfilled with peroxide for the four minute step.

Step 41 requires three minutes to complete. The blood side controlsequence opens the valve V₂ and turns the R.O. water pump P₁₇ on. Thisproduces a forward rinse in the blood side 124, thereby flushing theperoxide and blood components out and into the drain line. The dialysateside 122 control sequence places all valves in a normal condition,producing an open drain condition on the dialysate side 122. While Steps39, 40 and 41 are in progress, "detergent cycle 1" light 90 is lit.

Steps 42 and 43 each require thirty seconds to complete and represent atwo step air purge sub-sequence identical to the sub-sequence of Steps37 and 38. While Steps 42 and 43 are in progress, "air purge" light 92is lit.

Step 44 requires two minutes to complete and begins the second detergentcycle. The blood side control sequence opens the valve V₂ and closes thevalve V₈. The valve V₇ is opened. The sodium hypochlorite pump P₁₆ isturned on. The opening of the valve V₂ opens the blood side 124 to thehypochlorite line 161, and the closing of the valve V₈ closes the venusblood side drain line 166, thereby allowing the blood side 124 to fill.Turning the sodium hypochlorite pump P₁₆ on fills the blood side 124 ofthe dialyzer with sodium hypochlorite obtained from the sodiumhypochlorite reservoir 176. The dialysate side 122 control sequenceplaces all valves in their normal position, producing an open draincondition on the dialysate dise 122.

Step 45 requires two minutes to complete. The valve V₂ is closed and thepump P₁₆ is turned off for the blood side control sequence. Thisproduces a static condition in which the blood side 124 is filled withthe sodium hypochlorite for a period of two minutes. There is no changeon the dialysate side 122 of the dialyzer and the condition is,therefore, open to drain.

Step 46 requires two minutes to complete. The blood side controlsequence opens the valve V₂ and turns the R.O. water pump P₁₇ on. Thisproduces a forward rinse on the dialysate side 122, thereby flushing outthe sodium hypochlorite and blood components. The dialysate side 122valves remain in their normal position and the dialysate side is therebyopen to drain. While Steps 44, 45 and 46 are in progress, the "detergentcycle 2" light 94 is lit.

Steps 47 and 48 represent another air purge sub-sequence identical tothe sub-sequence comprising Steps 37 and 38. While steps 47 and 48 arein progress, "air purge" light 96 is lit.

Step 49 begins the pressure leak test and requires 30 seconds tocomplete. The blood side control sequence closes the valves V₇ and V₈and opens the valve V₁₁. In addition the air pressure pump P₁₄ is turnedon. The valve V₇ closes the arterial blood side drain line 146 and thevalve V₈ closes the venus blood side drain line 166. The opening of thevalve V₁₁ and the activation of the air pressure pump P₁₄ thereby servesto pressurize the blood side 124. The valves on the dialysate side 122are in their normal condition, and the dialysate side is, therefore,open to drain.

Step 50 requires 30 seconds to complete and comprises the performance ofa pressure leak test by means of a pressure sensor 158. The blood sidecontrol sequence closes the valve V₁₁ and turns the pump P₁₄ off. Apreferred pressure sensor which is commercially available is Bell &Howell Model 4-424-000-1.

The pressure sensor 158 measures the pressure drop from the blood side124 over a ten second period. If the pressure drop is no more than tenmillimeters of mercury over the ten second period, the dialyzer passesthe pressure leak test and the next step in the process is thensequenced. If the pressure drop is more than ten millimeters of mercuryover the ten second period, the dialyzer fails the test and the furthercleaning sequence is inhibited. This criterian of ten millimeters ofmercury over a ten second period was chosen since it represents agenerally recognized criteria for all dialyzers. While Steps 49 and 50are in progress, "pressure leak test" light 98 is lit. If the dialyzerfails the pressure leak test, the "pressure leak test failure" light 100is lit.

Step 51 requires four minutes to complete. The blood side controlsequence closes the valve V₇ and opens the valves V₈ and V₁₀. The R.O.water pump P₁₇ is turned on. Closing the valve V₇ closes the arterialblood side drain line 146, while opening the valve V₈ opens the venusblood side drain line 166. The opening of the valve V₁₀ and the turningon of the R.O. water pump thereby produces a reverse rinse through theblood side 124. The dialysate side 122 control sequence opens the valveV₁ and maintains the pump P₁₇ on. This produces a forward rinse on thedialysate side 122.

Step 52 requires three minutes to complete. The blood side controlsequence opens the valve V₁₂ and maintains the R.O. water pump P₁₇ on.This produces a forward rinse through the blood side 124. The valves inthe dialysate side 122 are in their normal position, producing an opendrain condition on the dialysate side 122. While Steps 51 and 52 are inprogress, "rinse" cycle light 102 is lit.

Step 53 represents the second blood level analysis and is the same asStep 36. Unlike Step 36, however, if the dialyzer 18 fails this bloodlevel analysis, the dialyzer 18 is rejected, and all further cleaningsequencing is inhibited. While Step 53 is in progress, the "second bloodlevel analysis failure" light 106 is lit.

The next step in the process, Step 54, is the ultrafiltration test. Thistest actually comprises a sub-sequence of three steps, i.e., Steps54a-c. The test indicates the hydraulic resistance of the membrane 123of the dialyzer to flow. The measurement may also be made in terms ofthe capacity of the membrane 123 to transmit fluids. Step 54a requires30 seconds to complete. The blood side control sequence opens the valveV₂, closes the valve V₇ and turns the RO water pump P₁₇ on, which allowsthe blood side 124 to fill with RO water. The dialysate side controlsequence is to place the valves in their normal position, therefore,functioning to open the dialysate side to drain. Step 54b requires 30seconds to complete. The blood side control sequence is to open thevalve V₁₁ and turn the pressure pump P₁₄ on. This sequence applies anair pressure of 10 pounds per square inch to the blood side 124. Thedialysate side control sequence and functions are the same as is Step54a. Step 54c requires 20 seconds to complete. The blood side controlsequence is to close the valve V₁₁ and to turn the pressure pump P₁₄off. After a three minute wait, the pressure sensor 158 measures theultrafiltration rate. The dialysate side control sequences and functionremains the same as in the previous steps. If the pressure measurementis not less than 250 mm of mercury, nor more than 350 mm of mercury, thedialyzer passes the ultrafiltration test. If the pressure is more than350 mm of mercury, this indicates that the membrane 123 is clogged withblood components or other matter, and is therefore not acceptable.Conversely, if the pressure is less than 250 mm of mercury, thisindicates an abnormality in the membrane 123, such as, a tear. If thedialyzer fails this test, the dialyzer is rejected. While theultrafiltration rate test is in progress, the "ultrafiltration ratetest" light 108 is lit. A failure of the dialyzer is shown by thelighting of the "ultrafiltration rate test failure" light 110. Theultrafiltration rate analyzer is the pressure sensor 158 which was usedin the pressure leak test described above. The preferred analyzer is thecommercially available Bell & Howell model 4-424-000-1.

The dialysate side 122 control sequence places the valves in theirnormal position and, therefore, the dialysate side 122 is open to drainduring the ultrafiltration rate test.

The ultrafiltration rate test is the last of the three basic tests whichare performed during the cleaning process to determine whether thedialyzer 18 will be able to be reused. The three basic tests are theblood pressure test, the pressure leakage test and the ultrafiltrationrate test. Each indicates the reusability of the dialyzer being cleaned,and has a predetermined criterian which must be met in order for thedialyzer to pass. If the dialyzer 18 fails any one of the three tests,the dialyzer 18 is rejected and the cleaning sequence is terminated. Thedialyzer status is displayed by the dialyzer status lights 72 and 74.Thus, if the dialyzer is acceptable, the dialyzer status light 72 islit, whereas, if the dialyzer is rejected, the dialyzer reject light 74is lit.

These tests represent an important feature of the invention, since theyprovide a check on the cleaning process during its progress. An earlyrecognition of an unacceptable dialyzer 18 provides time and costsavings to the process, as well as insuring that any dialyzer 18 whichis to be used meets all of the specified criteria.

Steps 55 and 56 represent another air purge sub-sequence identical tothe sub-sequence comprising Steps 37 and 38. While Steps 55 and 56 arein progress, "air purge" light 112 is lit.

The next step in the process is the disinfectant cycle, which beginswith Step 57. In Step 57, the blood side 124 control sequence opens thevalve V₄, opens the valve V₇ closes valve V₈ and turns the formalin pumpP₁₅ on. The closing of the valve V₈, closes the venus blood side drainline 166. The opening of the valve V₄ opens the venus formalin line 164.When the formalin pump P₁₅ is actuated, formalin is pumped into theblood side 124. As earlier discussed, formalin is only one of severalpossible disinfectants. Any suitable sterilizing medium is within thescope of this invention. While the blood side is being filled withformalin, the valves of the dialysate side are in a normal position, andthe dialysate side is thereby open to drain.

In Step 58, the valve V₄ is closed, so that the blood side 124 is thenin a static condition filled with formalin. The dialysate side 122control sequence opens the valve V₅, opens the valve V₆, closes V₉ andmaintains the pump P₁₅ on. The opening of the valve V₅ opens the venusdialysate side formalin line 134, while the closing of the valve V₉closes the venus dialysate side drain line 138. When the pump P₁₅ isactuated, formalin is pumped into the dialysate side 122 in a dialysatefill function.

In Step 59, no change occurs on the blood side 124 so that the bloodside 124 remains filled with formalin. The valve V₅ is closed and thepump P₁₅ turned off and, therefore, the dialysate side 122 is also in astatic condition filled with formalin. The dialyzer can be maintained inthis sterilized condition for as long as necessary. While Steps 57, 58,and 59 are in progress, "disinfectant cycle" light 114 is lit.

Upon completion of the disinfectant cycle, the cleaning process iscomplete, which is shown by lighting of the "cleaning complete" light115. The dialyzer 18 is then manually disconnected. The operator thenhas a choice with respect to resequencing the machine to prepare forcleaning the next dialyzer. First, he may manually actuate the stationpreparation switch 40 which sets the station at Step 3 to begin thestation preparation cleaning sequence. However, if the station hasrecently been disinfected from the disinfect cycle used to complete thecleaning of the previous dialyzer, the operator may press reset switch118 which resets the sequence to Step 13. This begins the identificationphase and in effect bypasses the station preparation cycle.

The next step is to manually clean the dialyzer 18 externally withdisinfectant, and to then manually bag and seal the dialyzer beforestorage. This step is important for preventing or reducing thepossibility for cross contamination or the growth of virus such ashepatitis.

The last step in the process is to actuate the secured station switch120, which produces the machine operations of disinfecting the controland hydraulic circuits and to secure the station.

Having described the cleaning process and the mechanical hardware, theelectronics utilized to control this process will be described withreference to FIG. 3. A standard electronic memory, shown generally as208, consists of an address portion 210 and a data portion 212. Theaddress portion 210 provides a numerical series corresponding in orderto the step sequences of the process. Each address is used to access acorresponding data word which provides the information necessary toperform a particular process step. More than one word may be requiredfor some steps, as where there is a measurement to be taken.

An address register 214 is used to access the address portion 210 of thememory bank 208. This will, in turn, access the particular data wordwhich corresponds to that step. Thus, for example, when a particularnumber is placed in the register 214, information from the data portion212 of the memory bank 208, corresponding to an address 210 identical tothe particular number, is transmitted to a data register 216.

The data word provided at the data register 216 by the memory 208 isdivided into several bit positions. In the implementation shown, thesebit positions are hard wired to various control elements, registers,etc., as described below. Thus, a zero or one data bit, placed in aparticular bit location of the register 216, at a particular cleaningstep, by the memory 208, will activate or deactivate a particularcontrol element, as described below.

As shown in the Figure, the first portion of the word consists ofmultiple bits which control the panel light system relating to thesequence of cleaning steps, phases 1 and 2, beginning with the prerinsestep to notify the operator of the progress of the cleaning cycles.These lights are found in the Sections 75 and 77 on panel 36 asdescribed earlier. As an example, the first bit 218 controls a singleone of the panel lights. Thus, the "prerinse" light 80 is lit if the bit218 is one, but is not lit if the bit 218 is zero. Each of the panellights of cleaning phases 1 and 2, would have a corresponding data bitin the first portion of the data word. All of these bits are not shown,to simplify the drawing. Thus, for the various cleaning steps,particular lights on the control panel 36 should be illuminated. Eachdata field 212 in the memory 208 will include a control bit for eachpanel light, so that, when the data field is transferred to the register216, the proper lights will be activated.

The second portion of the data word relates to information for thevalves, pumps and data reader. For example, a one data bit placed atlocation 219 when the data word is transferred from the memory 208,would produce a signal to a valve driver 221 which, in turn, would openor close a particular valve 223. The same principal is true with respectto the pumps, in which a one in a selected bit location activates aselected pump, while a zero produces a signal to a pump driver whichturns the pump off. Finally, in this same data group, a one data bit inan additional predetermined location within the data word is used foractuating a data reader 240 which will then receive photo-optical input239 which is used to read the dialyzer type and patient number, asdescribed earlier. As shown with the lights, all of the control bits arenot shown.

A third portion of the data word provides the time required to performeach particular step, written in binary code. At the beginning of eachstep, this time code is loaded into the counter 225. The counter iscontinually supplied with pulses from a clock 227, and counts down fromthe loaded time value at a rate determined by the frequency of the clock227. When the count is exhausted, the down counter produces a signal online 229 indicating that the loaded time value has expired.

The next portion of the data word is a group of decision bits, the firstbit 222 of which is used to activate the blood level analysis testdescribed above. A one data bit at location 222 indicates that no bloodlevel analysis is to be performed, at a particular process step. Thisone bit provides an input through an AND gate 224 to and AND gate 220.Thus, when the binary decision bit 222 is a one, the AND gate 220 willpermit an output signal on line 229, indicating that the count isexhausted from the down counter 225, to increment the address register214, thereby allowing the process to continue to the next step in thecleaning sequence.

Referring again to the decision bit 222, if the binary information is azero at a particular process step, this means that a decision must bemade. The binary zero at the bit 222 is inverted at an inverter 230, andtransmitted to enable an output signal from a blood analysis addressregister 232. The blood level analysis register 232 contains an addressC and an address D.

The address C is the address for step 48, and is enabled by a low signalfrom the differential amplifier 206. Thus, if the blood level analysistest, described previously, indicates a satisfactory blood level, theaddress C will be loaded into the address register 214, containing thecleaning process at step 48. However, if the blood level is determinedto be high from the blood level analysis, address D provides the addressfor step 37, which will be loaded into the address register 214. Thus,if the dialyzer fails to pass the first blood level analysis test, thecleaning process will proceed at step 37. This system therefore, allowsthe selection of cleaning step sequences depending upon the pass orfailure of the first blood level analysis test. In short, if thedialyzer fails the test, it undergoes additional step Nos. 37 through47, whereas, if the dialyzer passes the test, the cleaning procedurejumps to step 48.

A similar decision bit 233 is used to control the second blood leveltest at step 53. Thus, a binary zero at the bit 233 during a particularcleaning step is inverted at an inverter 239, and used to selectaddresses E or F for loading into the register 214, to provide continuedcleaning if the dialyzer passes the test, or a stop in the cleaningprocess if it fails. This stop command will be described below.Likewise, the pressure level test will enable one of registers G or H,when the decision bit 235 is loaded with a zero and inverted at aninverter 241 for particular process step, to continue the cleaningprocess at step 51, or to stop the cleaning process, respectively.Finally, the ultrafiltration rate test will enable one of the registersI or J, when the decision bit 237 is loaded with a zero, and inverted atan inverter 243, to continue the process at step 54 or stop the cleaningprocess, respectively.

The next decision bit 234 requires a determination of the particulardialyzer type which is sensed by the data reader. If the decision bit234 contains a zero code, a signal will be produced which is inverted atan inverter 236, which enables the dialyzer type address register 238.Dialyzer type address register 238 contains an address A and an addressB portion. The particular dialyzer type, as was discussed before, isdetermined by the data reader 240. Upon identifying the dialyzer type,the data reader inputs a signal to a dialyzer type register 242,enabling either the A or B address. The dialyzer type is coded either asa zero, which refers to a hollow fiber dialyzer or a one, which isidentified as a parallel plate or coil type dialyzer. The informationbit with respect to the hollow fiber type dialyzer is shown as 244 andthe bit with respect to the parallel plate or coil dialyzer is shown as246. Data bit 244, if a one, will produce an enable signal to theaddress A portion of the dialyzer type address register 238. Similarly,if the dialyzer type is a parallel plate or coil type dialyzer, a signalwill be produced from data bit 246 to enable the address B portion ofthe dialyzer type address register 238. The address A provides theaddress for step 26, whereas, the address B provides the address forstep 32. In summary, if decision bit 234 is zero, it will produce asignal which is transferred to enable the dialyzer type address register238. Then, depending upon the dialyzer type which is sensed by the datareader, the address register 241 will be loaded with either step 26address, corresponding to a cleaning process for a hollow fiber typedialyzer, or step 32, corresponding to a cleaning process for a parallelplate or coil dialyzer.

It should be noted that using the process described above, decision bit222 will be a zero only at the location in the memory 208 which storesthe data for process step 36, bit 233 only at step 53, bit 234 only atstep 25, bit 235 only at step 50, and bit 237 only at step 54.

As discussed above, in order to begin the cleaning sequence, theoperator pushes the power on switch 38. At the end of the cleaningsequence, the operation may actuate the station preparation switch 40,which produces a signal that enables a third step address register 256which, in turn, loads the address register 214 with the address of thethird step of the process, i.e., the beginning of the stationpreparation cycle. However, if the machine is already in a sterilizedcondition due to a recently completed disinfectant cycle sequence duringthe cleaning of a previous dialyzer, the operation may press the resetswitch 118. The switch 118 produces a signal that enables an address 254which provides the address for step 13. The address 254 will therebyload the address register 214 with the address of the thirteenth step ofthe process. This bypasses the station preparation cycle and returns thestation to the beginning of the identification phase discussed earlier.

Three data bits 272, 274 and 276, are utilized to illuminate lights 48,50 and 52, respectively, on the front panel 36. When one of these bitsis loaded with a one from a data word from the memory 208, a signal willbe inputed to the AND gate 224 to allow incrementing the sequence. Whenone of the bits 272, 274, and 276 is loaded with a zero, the zero isinverted at three inverters 288, 290 and 292, respectively and aspecific light on the panel 36 will be lit. In addition, each of thesebits is connected as one input of an AND gate 278, 280 and 282,respectively. The other input of these AND gates is connected to thedialyzer type register 242, a patient number register 284, and a stationnumber register 286, to enable the gates 278, 280, 282, when theoperator has input, respectively, the dialyzer type, patient number orstation number. As an example, when the bit 272 is a zero, at aparticular process step, the light 48 will illuminate, notifying theoperator that the station number data should be input. The operatorsignal will then depress the particular station number switch whichcorresponds to its particular station. Pressing the switch 42 on thepanel 36 enables a station number register 273 which is loaded with thepreparation number and inputs it into the station number register 286.The station number 286 after receiving the station number identificationwill enable the station number display 44. The combination of thestation number input at 286, and a zero bit at bit position 272,inverted at 288, will produce an output signal from an AND gate 278 tothe increment line, incrementing the address register 214 to the nextstep in the cleaning sequence. Likewise, the inverters 290 and 292invert a zero bit at positions 274 and 276 to illuminate the lights 50and 52, and to enabel the AND gates 280 and 282 when a patient number ordialyzer type is present at registers 284 and 282, respectively. Theoutput of the AND gates 218, 280 and 282 passes through an OR gate 203which, in turn, leads to incrementing of the address register 214 whenthe proper data is input to the system. If the proper data is notinputed into the system at the proper step of the sequence, all furthersequencing is thereby inhibited.

It will be noted that, in the cleaning sequence described above, bitpositions 272, 274 and 276 of the register 216 will be loaded with azero only at steps 13, 14 and 15 respectively.

The ability of the system to inhibit further sequencing will now bedescribed.

A stop bit 260, when provided with a zero bit in a special command wordfrom the memory 208, is utilized to inhibit further system sequencing.This step is used in the case of a failure of the dialyzer to meetspecific cleaning tests, specifically, those tests which occur at steps50, 53, and 54 that is, those tests which generate an address fromaddress F, address H, or address J registers. Each of these addressregisters F, H and J, will provide the same address signal to the memory208 to provide this special data word. The data word provides a normalposition for all valves and pumps within the system, while the zero bitat location 260, through the AND gate 224, will inhibit the AND gate 220and thus, inhibit further system sequencing. In addition, the zero bitat position 260 through the inverter 261, will energize the dialyzerreject status light 74 on the panel 36. As an additional indication ofthe source of dialyzer failure, when an output signal is provided byaddress F, H or J, a specific malfunction light 106, 100, or 110respectively will be illuminated on the front panel 36.

A second step bit 262 is used to inhibit further sequencing if amalfunction occurs in the system during cycling. If stop bit 262 iszero, it disables the system, by inhibiting the AND gate 220. Theaddress of the memory location, containing a zero bit in location 262 isprovided by an address K register 264 which is connected by an OR gate266 to the system malfunction sensors. When a malfunction occurs, thisaddress is loaded into the address register 214, providing the stopcommand instruction to the data register, and a zero bit in the bitposition 262. All other valves will be placed in their normal position.Each malfunction sensor is, in addition, connected to a specific light54-70 on the panel 36 to warn the operator of the location of themalfunction.

The use of the patient number to indicate the number of times a dialyzerhas been cleaned, as well as its use in preventing a rejected dialyzerfrom being reused, will now be described.

A dialyzer use register 302 stores, as separate data bytes, a list ofpatient numbers 304 correlated with a count designation 306. Initially,the count designations 306 will all contain a zero count. Whenever apatient number is entered at the data reader 240, this patient number isinput to a search and access circuit 308, which cycles the data in thememory 302 until a matching patient number has been located. Thus, ineffect, the patient number from the data input 240 is used to addressthe memory 302. Once addressed, the memory 302 supplies to a register310 the use count, that is, the number of times the dialyzer haspreviously been cleaned. The register 310 is connected to an incrementer312, which adds a count of 1 to the previous number of uses, andresupplies this new count to the data field 306 of the memory 302 in thesame location where the count was initially accessed. Thus, the countfor this specific patient will be incremented. The incrementer 312 isalso connected to a printer 250, which supplies, with other printedoutput data, the total number of times that this patient's dialyzer hasbeen cleaned at the end of the current cleaning cycle. It should beunderstood that, when new patients are entered into the system, newpatient numbers are placed in the patient number field 304 of the memory302, with a zero count.

The memory 302 has, as another important function, prohibiting use of adialyzer which has previously been rejected during a cleaning cycle. Theoutput of the inverter 261, described previously, is connected to aregister 314 containing all zeros for the entire data field 304 and 306of the memory 302. Since the memory 302 will be addressed at thebeginning of the cleaning cycle to the particular patient whose dialyzeris being cleaned during the cleaning process, a failure signal from theinverter 261 will enable the zero register 314 to write zeros for thepatient number and the number of uses, thus, in effect, erasing thepatient number from the memory 302. At a later time, an operator, usinga memory data reader 316 and an additional photo-optical input source318, can search the memory 302 to determine whether the patient numberon a specific dialyzer exists in the memory 302. If the patient numberexists in the patient number field 304 of the memory 302, an outputsignal will be provided on line 320, illuminating a light on the frontpanel 36 notifying the operator that the dialyzer is satisfactory foradditional use. If, on the other hand, the patient number has beenremoved from the memory 320 by writing zeros from the register 134, asignal will appear on line 322, illuminating a light on the panel 36,notifying the operator that the dialyzer should be discarded and notused.

Data bit 248 contains the data information necessary to enable theprinter 250. A one bit produces a signal enabling the printer 250 toprint out the particular information sought to be recorded, for example,the day, data and time of the cleaning operation which is generated by aday, data and timeclock 252. In addition, the dialyzer type sensed bythe data reader 240 and inputed to the dialyzer type register 252, thepatient number also sensed by the data reader and inputed to the patientnumber register 284, and the station number, which is punched in by theoperator using switch 42 and inputed to station number register 286, areall printed out when printer 250 is enabled.

                                      TABLE 1                                     __________________________________________________________________________    STEP.   BLOOD SIDE                                                                             BLOOD SIDE                                                                            DIALYSATE SIDE                                                                           DIALYSATE                                 NO. TIME                                                                              CONTROL SEQ.                                                                           FUNCTION                                                                              CONTROL SEQ.                                                                             SIDE FUNCTION                             __________________________________________________________________________    3   17 sec.                                                                           V.sub.2 open                                                                           Forward rinse                                                                         V.sub.1 open                                                                             Forward rinse                                     P.sub.17 on      P.sub.17 on                                          4   34 sec.                                                                           V.sub.7 closed                                                                         Air purge                                                                             V.sub.1 open                                                                             Forward rinse                                     V.sub.8 open     P.sub.17 on                                                  V.sub.11 open                                                                 P.sub.14 on                                                           5   34 sec.                                                                           V.sub.7 closed                                                                         Reverse rinse                                                                         V.sub.1 open                                                                             Forward rinse                                     V.sub.8 open     P.sub.17 on                                                  V.sub.11 closed                                                               V.sub.10 open                                                                 P.sub.17 on                                                           6   34 sec.                                                                           V.sub.2 open                                                                           Forward rinse                                                                         V.sub.1 open                                                                             Forward rinse                                     P.sub.17 on      P.sub.17 on                                          7   34 sec.                                                                           V.sub.7 closed                                                                         Air purge                                                                             V.sub.1 open                                                                             Forward rinse                                     V.sub.8 open     P.sub.17 on                                                  V.sub.11 open                                                                 P.sub.14 on                                                           8   34 sec.                                                                           V.sub.7 closed                                                                         Reverse rinse                                                                         V.sub.1 open                                                                             Forward rinse                                     V.sub.8 open     P.sub.17 on                                                  V.sub.11 closed                                                               V.sub.10 open                                                                 P.sub.17 on                                                           9   34 sec.                                                                           V.sub.2 open                                                                           Forward rinse                                                                         V.sub.1 open                                                                             Forward rinse                                     P.sub.17 on      P.sub.17 on                                          10  34 sec.                                                                           V.sub.7 closed                                                                         Air purge                                                                             V.sub.1 Open                                                                             Forward rinse                                     V.sub.8 Open     P.sub.17 On                                                  V.sub.11 Open                                                                 P.sub.14 On                                                           11  34 sec.                                                                           V.sub.7 Closed                                                                         Reverse V.sub.1 Open                                                                             Forward rinse                                     V.sub.8 Open                                                                           rinse   P.sub.17 On                                                  V.sub.11 Closed                                                               V.sub.10 Open                                                                 P.sub.17 On                                                           __________________________________________________________________________

                                      TABLE 2                                     __________________________________________________________________________    STEP.   BLOOD SIDE                                                                             BLOOD SIDE                                                                            DIALYSATE SIDE                                                                           DIALYSATE                                 NO. TIME                                                                              CONTROL SEQ.                                                                           FUNCTION                                                                              CONTROL SEQ.                                                                             SIDE FUNCTION                             __________________________________________________________________________    17  17 sec.                                                                           V.sub.2 open                                                                           Forward rinse                                                                         V.sub.1 open                                                                             Forward rinse                                     P.sub.17 on      P.sub.17 on                                          18  34 sec.                                                                           V.sub.7 closed                                                                         Air purge                                                                             V.sub.1 open                                                                             Forward rinse                                     V.sub.8 open     P.sub.17 on                                                  V.sub.11 open                                                                 P.sub.14 on                                                           19  34 sec.                                                                           V.sub.7 closed                                                                         Reverse rinse                                                                         V.sub.1 open                                                                             Forward rinse                                     V.sub.8 open     P.sub.17 on                                                  V.sub.11 closed                                                               V.sub.10 open                                                                 P.sub.17 on                                                           20  34 sec.                                                                           V.sub.2 open                                                                           Forward rinse                                                                         V.sub.1 open                                                                             Forward rinse                                     P.sub.17 on      P.sub.17 on                                          21  34 sec.                                                                           V.sub.7 closed                                                                         Air purge                                                                             V.sub.1 open                                                                             Forward rinse                                     V.sub.8 open     P.sub.17 on                                                  V.sub.11 open                                                                 P.sub.14 on                                                           22  34 sec.                                                                           V.sub.7 closed                                                                         Reverse rinse                                                                         V.sub.1 open                                                                             Forward rinse                                     V.sub.8 open     P.sub.17 on                                                  V.sub.11 closed                                                               V.sub.10 open                                                                 P.sub.17 on                                                           23  34 sec.                                                                           V.sub.2 open                                                                           Forward rinse                                                                         V.sub.1 open                                                                             Forward rinse                                     P.sub.17 on      P.sub.17 on                                          24  34 sec.                                                                           V.sub.7 Closed                                                                         Air purge                                                                             V.sub.1 Open                                                                             Forward rinse                                     V.sub.8 Open     P.sub.17 On                                                  V.sub.11 Open                                                                 P.sub.14 On                                                           25  34 sec.                                                                           V.sub.7 Closed                                                                         Reverse V.sub.1 Open                                                                             Forward rinse                                     V.sub.8 Open                                                                           rinse   P.sub.17 On                                                  V.sub.11 Closed                                                               V.sub.10 Open                                                                 P.sub.17 On                                                           __________________________________________________________________________

                                      TABLE 3                                     __________________________________________________________________________    STEP    BLOOD SIDE                                                                             BLOOD SIDE                                                                            DIALYSATE SIDE                                                                           DIALYSATE                                 NO. TIME                                                                              CONTROL SEQ.                                                                           FUNCTION                                                                              CONTROL SEQ.                                                                             SIDE FUNCTION                             __________________________________________________________________________    26  4 Min.                                                                            V.sub.8 Open                                                                           "Squeezing"                                                                           V.sub.1 Open                                                                             Forward rinse                                              of blood side                                                                         V.sub.6 Closed                                                        reverse ultra-                                                                        P.sub.17 On                                                           filtration                                                   27  2 Min.                                                                            V.sub.7 Closed                                                                         Reverse V.sub.9 Open                                                                             Drain open                                        V.sub.8 Open                                                                           rinse                                                                V.sub.10 Open                                                                 P.sub.17 On                                                           28  2 Min.                                                                            V.sub.2 Open                                                                           Forward V.sub.9 Open                                                                             Drain open                                        P.sub.17 On                                                                            rinse                                                        29  4 Min.                                                                            V.sub.8 Open                                                                           "Squeezing"                                                                           V.sub.1 Open                                                                             Forward rinse                                              of blood side-                                                                        V.sub.6 Close                                                         reverse ultra-                                                                        P.sub.17 On                                                           filtration                                                   30  2 Min.                                                                            V.sub.7 Closed                                                                         Reverse V.sub.9 Open                                                                             Drain open                                        V.sub.8 Open                                                                           rinse                                                                V.sub.10 Open                                                                 P.sub.17 On                                                           31  2 Min.                                                                            V.sub.2 Open                                                                           Forward V.sub.9 Open                                                                             Forward rinse                                     P.sub.17 On                                                                            rinse                                                        __________________________________________________________________________

                  TABLE 4                                                         ______________________________________                                        32  4 Min.  V.sub.2 Open                                                                             Forward V.sub.9 Open                                                                          Drain open                                         P.sub.17 On                                                                              rinse                                                  33  4 Min.  V.sub.7 Closed                                                                           Reverse V.sub.9 Open                                                                          Drain open                                         V.sub.8 Open                                                                             rinse                                                              V.sub.10 Open                                                                 P.sub.17 On                                                       34  4 Min.  V.sub.2 Open                                                                             Forward V.sub.9 Open                                                                          Drain open                                         P.sub.17 On                                                                              rinse                                                  35  4 Min.  V.sub.7 Closed                                                                           Reverse V.sub.9 Open                                                                          Drain open                                         V.sub.8 Open                                                                             rinse                                                              V.sub.10 Open                                                                 P.sub.17 On                                                       ______________________________________                                    

                                      TABLE 5                                     __________________________________________________________________________    STEP    BLOOD SIDE                                                                             BLOOD SIDE                                                                            DIALYSATE SIDE                                                                           DIALYSATE                                 NO. TIME                                                                              CONTROL SEQ.                                                                           FUNCTION                                                                              CONTROL SEQ.                                                                             SIDE FUNCTION                             __________________________________________________________________________    36  1 Min.                                                                            Valves in                                                                              Blood test                                                                            Valves in  Open to drain                                     normal pos-                                                                            of effluent                                                                           normal                                                       ition            position                                             37  30 sec.                                                                           Valves in                                                                              Open to V.sub.6 Closed                                                                           Air Purge                                         normal   drain                                                                position         V.sub.9 Open                                                                  V.sub.12 Open                                                                 P.sub.14 On                                          38  30 sec.                                                                           V.sub.7 Closed                                                                V.sub.8 Open                                                                           Air purge                                                                             Valves in  Open to drain                                                      normal                                                                        condition                                                    V.sub. 11 Open                                                                P.sub.14 On                                                           39  3 Min.                                                                            V.sub.3 Open                                                                           Peroxide                                                                              Valves in  Open to drain                                              fill    normal                                                                        condition                                                    V.sub.7 Open                                                                  V.sub.8 Closed                                                                P.sub.13 On                                                           40  4 Min.                                                                            V.sub.3 Closed                                                                         Peroxide                                                                              No change  Open to drain                                              wait                                                                 P.sub.13 Off                                                          41  3 Min.                                                                            V.sub.2 Open                                                                           Peroxide                                                                              Valves in  Open to drain                                     P.sub.17 On                                                                            flush   normal                                                                forward condition                                                             rinse                                                        42  30 sec.                                                                           Valves in                                                                              Open to V .sub.6 Closed                                                                          Air purge                                         normal   drain   V.sub.9 Open                                                 position         V.sub.12 Open                                                                 P.sub.14 On                                          43  30 sec.                                                                           V.sub.7 Closed                                                                V.sub.8 Open                                                                           Air purge                                                                             Valves in  Open to drain                                     V.sub.11 Open    normal                                                       P.sub.14 on      condition                                            44  2 Min.                                                                            V.sub.2 Open                                                                           Sodium  Valves in  Open to drain                                     V.sub.7 Open                                                                           hypochlorite                                                                          normal                                                       V.sub.8 Closed                                                                         fill    condition                                                    P.sub.16 On                                                           45  2 Min.                                                                            V.sub.2 Closed                                                                         Sodium  No change  Open to drain                                     P.sub.16 Off                                                                           hypochlorite                                                                  wait                                                         46  2 Min.                                                                            V.sub.2 Open                                                                           Sodium  Valves in  Open to drain                                     P.sub.17 On                                                                            hypochlorite                                                                          normal                                                                flush   position                                             47  30 sec.                                                                           Valves   Open to V.sub. 6 Closed                                                                          Air Purge                                         in normal                                                                              Drain   V.sub.9 Open                                                 position         V.sub.12 Open                                                                 P.sub.14 On                                          48  30 sec.                                                                           V.sub.7 Closed                                                                V.sub.8 Open                                                                           Air Purge                                                                             Valves in  Open to drain                                     V.sub.11 Open    normal                                                       P.sub.14 On      condition                                            49  30 sec.                                                                           V.sub.7 Closed                                                                         Blood side                                                                            Valves in  Open to drain                                     V.sub.8 Closed                                                                         pressurized                                                                           normal                                                       V.sub.11 Open    position                                                     P.sub.14 On                                                           50  30 sec.                                                                           Perform pres-                                                                          Measure Valves in  Open to drain                                     sure leak test                                                                         pressure                                                                              normal                                                       V.sub.11 Closed                                                                        drop over                                                                             position                                                     P.sub.14 Off                                                                           10 seconds                                                   51  4 Min.                                                                            V.sub.7 Closed                                                                         Reverse V.sub.1 Open                                                                             Forward                                           V.sub.8 Open                                                                           rinse   P.sub.17 On                                                                              rinse                                             V.sub.10 Open                                                                 P.sub.17 On                                                           52  3 Min.                                                                            V.sub.2 Open                                                                           Forward Valve in   Open to drain                                     P.sub.17 On                                                                            rinse   normal position                                      53  1 Min.                                                                            Valves in                                                                              Blood test                                                                            Valve in   Open to drain                                     noraml   of effluent                                                                           normal position                                              position                                                              54a 30 Sec.                                                                           V.sub.2 Open                                                                           Fill with                                                                             Valves in  Open to drain                                     V.sub.7 Closed                                                                         R/O water                                                                             normal position                                              P.sub.17 On                                                           54b 30 Sec.                                                                           V.sub.11 Open                                                                          Apply 10 psi                                                                          Valves in  Open to drain                                     P.sub.14 On      normal position                                      54c 20 Sec.                                                                           V.sub.11 Closed                                                                        Measure ultra-                                                                        Valves in  Open to drain                                     P.sub.14 Off                                                                           filtration                                                                            noraml                                                                rate after                                                                            position                                                              3 minute wait                                                55  30 Sec.                                                                           Valves in                                                                              Open to V.sub.6 Closed                                                                           Air purge                                         normal   drain   V.sub.9 Open                                                 position         V.sub.12 Open                                                                 P.sub.14 On                                          56  30 Sec.                                                                           V.sub.7 Closed                                                                         Air purge                                                                             Valves in  Open to drain                                     V.sub.8 Open     normal                                                       V.sub.11 Open    condition                                                    P.sub.14 On                                                           57      V.sub.4 Open                                                                           Fill with                                                                             Valves in                                                    V.sub.7 Open                                                                           formalin                                                                              normal position                                              V.sub.8 Closed                                                                P.sub.15 On                                                           58      V.sub.4 Closed                                                                         Filled with                                                                           V.sub.5 Open                                                                             Fill with                                                  formalin                                                                              V.sub. 6 Open                                                                            formalin                                                           V.sub.9 Closed                                                                P.sub.15 On                                          59      No change                                                                              Filled with                                                                           V.sub.5 Closed                                                                           Filled with                                                formalin                                                                              P.sub.15 Off                                                                             formalin                                  __________________________________________________________________________

We claim:
 1. A system for cleaning a dialyzer having a blood side and adialysate side separated by a membrane comprising:means for storing afirst predetermined sequence of cleaning procedures, said first storingmeans providing first control signals; means for storing a secondpredetermined sequence of cleaning procedures, said second storing meansproviding second control signals; means for regulating the flow of aplurality of blood cleaning reagents through the dialysate and bloodsides of the dialyzer; means responsive to said first control signalsfor automatically controlling said regulating means to provide saidcleaning procedures in said first predetermined sequence; means formonitoring the condition of said dialyzer during said firstpredetermined sequence of cleaning procedures; and means responsive tosaid monitoring means for selectively controlling the sequencing of thecleaning procedures in said second predetermined sequence in response tothe condition of said dialyzer to prohibit the use of defectivedialyzers.
 2. The system of claim 1 wherein said controlling meansinhibits said second predetermined sequence of cleaning procedures. 3.The system of claim 1 wherein said controlling means alters the order ofsaid second predetermined sequence of cleaning procedures.
 4. The systemof claim 1 wherein said controlling means selects specific steps fromsaid second predetermined sequence of cleaning procedures to clean saiddialyzer.
 5. The system of claim 1 wherein said monitoring meansmeasures indicia of useability of said dialyzer.
 6. The system of claim5 further comprising means for storing predetermined criteria which adialyzer must meet in order to be useable.
 7. The system of claim 6wherein said controlling means inhibits said second predeterminedsequence of cleaning procedures if said indicia of useability measuredby said monitoring means do not meet said predetermined criteria.
 8. Thesystem of claim 1 wherein said monitoring means measures the level ofblood components remaining in the blood side effluent of the dialyzer.9. The system of claim 8 wherein said monitoring means measures theconcentration of hemoglobin present in an effluent obtained from rinsingsaid blood side.
 10. The system of claim 1 wherein said monitoring meansmeasures pressure leakage from the blood side of said dialyzer.
 11. Thesystem of claim 1 wherein said monitoring means measures the pressuredrop in a 10 second period from the blood side after said blood side hasbeen pressurized.
 12. The system of claim 1 wherein said monitoringmeans measures the ultra-filtration rate of a fluid through the membraneof the dialyzer over a period of time.